Engineer, Process Engineering

About the position

The Engineer will support ongoing activities by assisting in troubleshooting mechanical problems, identifying improvements in utilities to minimize interruptions (down time) and reduce energy usage/cost, and supporting new and ongoing projects. This position will further assist in the management and planning of project budgets and schedules and provide contractor oversight. This position will assist in identifying, tracking, forecasting, and implementing capital expenditure projects by working with site leadership and departmental end users to identify the correct project parameters and utility requirements. The Engineer may establish new Standard Operating Procedures (SOPs) and/or recommend changes to current SOPs based on facility needs. This person will work on complex facility-related problems requiring in-depth data analysis to determine appropriate action. The Engineer is expected to have extensive ongoing communication with employees and cross-functional group managers/departments on facility-related issues.

Responsibilities

• Support the multi-use facility, including HVAC systems and bio-containment systems
• Support selection and installation of manufacturing equipment
• Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements
• Draft SOPs for building operation, maintenance, and calibration
• Identify improvements and efficiencies of facility preventative maintenance
• Provide engineering guidance and execution on facilities and equipment projects
• Perform hands-on activities as needed to help troubleshoot facility problems and support facility staff
• Develop standard processes to evaluate future capital projects
• Drive continuity and development of standards in Project Engineering to ensure smooth and effective communication flow between internal resources and customers, operational efficiency, and equipment and personnel safety
• Create and maintain all aspects of equipment design files
• Maintain project compliance in accordance with the site quality management system
• Guide the specification and selection of manufacturing/utility equipment to support site facility/process needs
• Monitor, maintain, and repair existing production and laboratory control and monitoring systems (PLC, sub-networks, software, etc.)
• Apply and enhance existing automation validation programs for the validation of new and existing production and laboratory automated systems, including major capital projects and continuous improvement of systems
• Draft, review, execute, and approve protocols and reports related to Automation System Validation (CSV). This includes deviation reporting during execution
• Act as primary Subject Matter Expert (SME) for CSV
• Assist and manage production and laboratory system contractors as required
• Review and approve changes to computerized automation production and laboratory systems through the change control program to assess impact on validated systems
• Assist in responding to customer/regulatory audit observations and corrective actions as it pertains to automation system validation
• Identify and implement improvement opportunities for established production systems
• Collaborate significantly with cross functional groups including Validation, Quality Control, Manufacturing, Process Development, and Facilities
• Support local and global IT
• Manage software and hardware support agreements to ensure compliance and minimize cost impact. Manage third party contractors who may work on Catalent systems
• Provide technical assistance and training for personnel
• File and maintain controlled documents
• Complete knowledge of varied aspects or a single specialized aspect of a discipline and some knowledge of principles and concepts in other disciplines
• Apply technical and functional knowledge to conduct experiments/research in assigned area
• May act as a technical resource within own work group/project team
• Work independently to solve problems of moderate scope
• Actively participate and suggest solutions to problems
• Other duties as assigned

Requirements

• Bachelor's degree in chemical/mechanical/electrical engineering or appropriate scientific discipline, required, or 8 years of engineering experience in lieu of the degree
• PE / Registered Engineer in training, preferred
• OSHA 10 or equivalent a plus, preferred
• 2+ years of Project Engineering related experience
• Must be able to read and understand English-written job instructions and safety requirements
• Ability to use Excel, Word, and other office systems
• Ability to formulate complex and comprehensive materials such as authoritative reports and/or to create/deliver formal and informal presentations
• Ability to cross-train on techniques across multiple groups
• Ability to independently interpret data, analyze trends, and provide insight into potential issues and subsequent solutions
• Ability to complete investigation, deviation, and change control forms independently
• Proficient in operation and troubleshooting of a wide variety of instrumentation and data systems
• Ability to provide ideas, introduce new technology, and drive process improvements. Work with other groups to develop, qualify, and transfer methods accordingly
• Understanding and adherence to applicable regulatory authority and guidelines
• Write, edit, and review SOPs
• Exposure to contractual management and processes
• Problem-solving (Lean Six Sigma) and change management methodologies consistent with establishing a culture of continuous improvement is preferred
• Team leadership and project-management skills
• Understanding of proposal and project scope as it relates to pricing, resources management, and the impact on business
• Ability to operate within a clean room environment

Nice-to-haves

• PE / Registered Engineer in training
• OSHA 10 or equivalent
• Problem-solving (Lean Six Sigma) and change management methodologies

Benefits

• Leading pay and annual performance bonus for all positions
• Generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance - effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards